Swissmedic.ch

Homepage [www.swissmedic.ch]

WEBSwissmedic is the national authorisation and supervisory authority for drugs and medical products. The agency ensures that only high-quality, safe and effective medical products …

Actived: 9 days ago

URL: https://www.swissmedic.ch/swissmedic/en/home.html

Swissmedic, Swiss Agency for Therapeutic Products

WEBSwissmedic is the Swiss authority responsible for the authorisation and supervision of therapeutic products. Swissmedic's activities are based on the Law on Therapeutic …

Category: Health Go Health

Medicinal product information

WEBHuman medicines. Medicinal product information search platform (AIPS) with information for authorised human medicines. www.swissmedicinfo.ch.

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Access Consortium

WEBThe Access Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration (TGA), Health …

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Coronavirus disease (COVID-19) Pandemic

WEBSwissmedic approves bivalent Pfizer Ltd. COVID-19 Original / Omicron BA 4-5 booster dose for adults aged 12 and over. Bivalent Original / Omicron BA.4-5 mRNA vaccine …

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The Swissmedic Marketing Authorisation for Global Health …

WEBOn Tuesday, 23 February 2021, Swissmedic, in collaboration with the Swiss Development and Cooperation Agency, held a virtual event on the Procedure for Marketing …

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A study confirms Swissmedic’s international Competitiveness

WEBThe processing time in Switzerland for applications for new active substances (NAS) was 520 calendar days in 2019, i.e. 277 days more than for the FDA, the world's …

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Swissmedic extends the MAGHP procedure

WEB01.10.2020. The aim of the Marketing Authorisation for Global Health Products (MAGHP) programme is to make Swissmedic’s authorisation procedure accessible to regulatory …

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Updated requirements for dealing with potential nitrosamine …

WEBAnalytical testing for NDRSIs in category 1 or 2. Preparations from CPCA categories 1 or 2 must be analysed using validated and sufficiently sensitive methods. …

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Swissmedic confirmed as WHO Listed Authority

WEB01.11.2023. The WHO listed Swissmedic as a WHO Listed Authority (WLA) on 30th October 2023. Regulatory authorities that are listed as WLAs comply with international …

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Development Cooperation – Regulatory Systems Strengthening

WEBIn 2013 the Federal Council issued a revised mandate to Swissmedic to conduct projects in the area of development cooperation, in conjunction with the Swiss Agency for …

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Public Summary SwissPAR – Alhemo®

WEBThe medicinal product Alhemo contains the active substance concizumab. It is used to treat adults and adolescents aged 12 years and over with haemophilia B …

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HealthReg (Register of Entreprises)

WEBHealthReg. The MedReg register of medical professions and the Establishment Register BetReg are the authoritative registers listing all medical professionals, public …

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Reporting quality defects

WEBClass 1. Defects that are potentially life threatening or that could cause serious risk to health. Class 2. Defects which could cause illness or lead to inappropriate treatment, …

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Reporting/submitting suspected adverse drug reactions by

WEBMarketing Authorisation Holders (MAH) basically have two options for submitting suspected adverse drug reactions to Swissmedic: Electronic reports via the ElViS portal (Electronic …

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Pharmacovigilance

WEBThe Swissmedic National Pharmacovigilance Centre accepts and processes reports of adverse drug reactions from professionals. The National Pharmacovigilance Centre is …

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